The present invention provides systems and methods useful for delivering fluids to the ear canal of a patient. The systems and methods may be useful for anesthetizing the tympanic membrane and/or the ear canal of a patient in preparation for a surgical procedure, including the placement of a tympanostomy tube (or pressure equalization tube) across a tympanic membrane of an ear. Additionally, the invention provides systems and methods for delivering and/retaining fluid in the ear canal of a human patient for treatment of the ear canal or tympanic membrane.
Otitis media is among the most common diagnoses made by pediatricians. A majority of children may have at least one episode of otitis media (“ear infection”) prior to their third birthday. Otitis media is often caused by an inability of the eustachian tube to drain fluid from the middle ear. Otitis media is often treated with antibiotics.
A significant number of children exhibit recurrent episodes of otitis media and/or otitis media with effusion. Treatment of these more severe cases often involves the placement of a tympanostomy tube across the tympanic membrane to provide adequate drainage and/or ventilation of the middle ear and reduce the likelihood of future infections. Tympanostomy tubes provide fluid communication between the middle and outer ear (e.g., pressure equalization) and typically fall out spontaneously within about a year of placement. Tympanostomy tube placement is among the most frequent surgical procedures performed in the pediatric population. It has been estimated that more than a million tympanostomy tubes may be placed each year, with typical patients being between about 18 months and 7 years of age at the time of the procedure.
Tympanostomy tube placement is typically performed in an out-patient surgery setting under general anesthesia. After administering the general anesthesia, the physician typically first examines the external auditory canal and tympanic membrane under microscopic visualization through a hand-held conical shaped speculum. The physician then makes an incision in the tympanic membrane (a “myringotomy”), typically using a standard, small profile scalpel which the physician advances through the conical speculum. The physician may then pass a suction device through the myringotomy into the middle ear, to aspirate fluid/effusion from the middle ear. The physician will then place the tympanostomy tube across the tympanic membrane, typically using a basic tool, such as forceps, for holding and advancing the tube into the myringotomy.
Systems and methods have been proposed for deploying tympanostomy tubes without having to use general anesthesia. Such systems are described for example in US Publication No. 2011/001564 (Tympanic Membrane Pressure Equalization Tube Delivery System), US Publication No. 2010/0198135 (Systems and Methods for Anesthetizing Ear Tissue), US Publication No. 2009/0163848 (Iontophoresis Methods) and US Publication No. 2009/0262510 (Disposable Iontophoresis System and Tympanic Membrane Pain Inhibition Method) each of which is incorporated by reference in their entirety. These publications describe integrated methods for delivering tympanostomy tubes and appropriate anesthesia, however, simplified systems that provide for delivery of solution to the tympanic membrane with minimal discomfort to the patient are still desirable.
In light of the above, the present inventions are directed to improved devices, systems, and methods for delivering and retaining fluid in the ear canal of a patient. These improvements facilitate delivery and retention of an anesthetizing solution into the ear canal to prepare the tympanic membrane for tympanostomy tube placement without requiring multiple devices and operator-performed steps. At least some of these advantages may be provided by the embodiments described herein.